Product Description
Fexofenadine-HCL is an antihistamine drug used to treat seasonal allergies, hay fever, hives, and other forms of allergic reactions. It works by blocking the effects of histamine, a chemical released by the body during an allergic reaction. It is available in both over-the-counter and prescription forms.
Fexofenadine IP Indian Pharmacopoeia Short Specification
1 Chemical Name 41Hydroxy44hydroxydiphenylmethyl1piperidinylbutyl dimethylbenzeneacetic acid hydrochloride
2 Molecular Formula C32H39NO4HCl
3 Molecular Weight 53814 gmol
4 Appearance White to offwhite crystalline powder
5 Assay Contains not less than 980 and not more than 1020 of C32H39NO4HCl calculated on the anhydrous basis
6 Identification Infrared Absorption Spectrophotometry Chromatographic methods
7 Solubility Sparingly soluble in water freely soluble in methanol slightly soluble in ethanol
8 Melting Point Between 148C and 150C
9 Storage Store in a wellclosed container protected from light and moisture
Fexofenadine BP British Pharmacopoeia Short Specification
1 Chemical Name 41Hydroxy44hydroxydiphenylmethyl1piperidinylbutyl dimethylbenzeneacetic acid hydrochloride
2 Molecular Formula C32H39NO4HCl
3 Molecular Weight 53814 gmol
4 Appearance White to offwhite crystalline powder
5 Assay Contains 980 to 1020 of C32H39NO4HCl calculated on the anhydrous basis
6 Identification Infrared Absorption Spectrophotometry Chromatographic methods
7 Solubility Sparingly soluble in water freely soluble in methanol slightly soluble in ethanol
8 Melting Point Between 148C and 150C
9 Storage Store in a wellclosed container protected from light and moisture
Fexofenadine USP United States Pharmacopeia Short Specification
1 Chemical Name 41Hydroxy44hydroxydiphenylmethyl1piperidinylbutyl dimethylbenzeneacetic acid hydrochloride
2 Molecular Formula C32H39NO4HCl
3 Molecular Weight 53814 gmol
4 Appearance White to offwhite crystalline powder
5 Assay Contains 980 to 1020 of C32H39NO4HCl calculated on the anhydrous basis
6 Identification Infrared Absorption Spectrophotometry Chromatographic methods
7 Solubility Sparingly soluble in water freely soluble in methanol slightly soluble in ethanol
8 Melting Point Between 148C and 150C
9 Storage Store in a wellclosed container protected from light and moisture
These specifications ensure the quality purity and efficacy of fexofenadine according to the Indian Pharmacopoeia British Pharmacopoeia and United States Pharmacopeia
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